A Reflection of Educational Advancements In Undergraduate Medical Education From Pharmacological Perspective

Yıl 2019, Cilt: 3 Sayı: 1, 1 - 8, 30.04.2019

Evren Savlı , Evrim Savlı

Öz

Advances
in technology accompanied by the rapid accumulation of new knowledge force
higher education institutions to change the way in which they prepare their
graduates for healthcare delivery systems. Medical education administrators in
higher education should seek the appropiate curricular revisions that will
yield the improvements in the lifelong academic performance of undergraduate
medicine students. Adverse drug reactions and medical device incidents may
cause “serious health issues” as shown in literature. There is no international
standard exists for teaching pharmacovigilance at universities for
undergraduate medical, pharmacy, dentistry, nursing and midwifery students. The
aim of this review is to raise the awareness of the importance of pharmacovigilance,
ecopharmacovigilance and medical device incidents in pharmacology curriculum in
higher education and to underline the role of medical academics in encouraging
undergraduate students for appropiate reporting of adverse drug reactions and
medical device incidents to vigilance systems in accordance with national
regulations and also in promoting for proper waste management and safe disposal
of pharmaceuticals and personal care products. 

Anahtar Kelimeler

Pharmacovigilance, Medical education, Ecopharmacovigilance, Medical Device

Tıp Lisans Eğitiminde Eğitimsel İlerlemenin Farmakolojik Bakış Açısından Bir Yansıması

Öz

Teknolojideki
gelişmelere yeni bilginin hızlı birikiminin eşlik etmesi yüksek öğretim
kurumlarını sağlık bakımı sağlayıcı sistemler için mezunlarını hazırlama
şekillerini değiştirmeye zorlamaktadır. Yüksek öğretimdeki tıp eğitim
uygulayıcıları mezun olacak tıp öğrencilerinin yaşam boyu akademik
performanlarında ilerlemeler sağlayacak uygun ders programı revizyonlarını
araştırmalıdırlar. Advers ilaç reaksiyonlarının ve tıbbi cihaz olaylarının çok
ciddi sağlık sorunlarına yol açabileceği literatürde ortaya konmaktadır.
Üniversitelerde tıp, eczacılık, diş hekimliği, hemşirelik ve ebelik
öğrencilerine farmakovijilans öğretimi için bir uluslararası standart bulunmamaktadır.
Bu derlemenin amacı yüksek öğretimde farmakoloji ders programında
farmakovijilansın, ekofarmakovijilansın ve tıbbi cihaz olumsuz olaylarının
önemine dair bir farkındalık yaratmak ve tıp akademisyenlerinin mezun olacak
öğrencilerin advers ilaç reaksiyonlarını ve tıbbi cihaz olumsuz olaylarını
ulusal yasalarla uyumlu bir şekilde vijilans sistemine uygun raporlamasını
teşvik etmedeki ve uygun atık yönetiminin ve farmasötiklerin ve kişisel bakım
ürünlerinin güvenli atılımının desteklenmesindeki rolünün altını çizmektir.

Anahtar Kelimeler

Farmakovijilans, tıp eğitimi, ekofarmakovijilans, tıbbi cihaz

Kaynakça

• 1.WHO. The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products, 2002; 1-52.
• 2.WHO. Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines, 2004; 1-5.
• 3.UMC, cited 12.03.2019, https://www.who-umc.org/about-us/our-story/
• 4.TMMDA, Turkish Medicines and Medical Devices Agency, Turkish Pharmacovigilance Center, cited 14.02.2019 https://www.titck.gov.tr/faaliyetalanlari/ilac/farmakovijilans.
• 5.Official Gazette. Regulation on the monitoring and assessment of the safety of medicinal products for human use, 2005, cited 12.03.2019 http://www.resmigazete.gov.tr/eskiler/2005/03/20050322-7.htm.
• 6.Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs Real World Outcomes, 2016; 3(1):33–43.
• 7.Official Gazette. Regulatıon On The Safety Of Medıcınal Products By Turkish Medicines and Medical Devices Agency Legislation on Drug Safety, 2014; Official Gazette No: 28973 2014.
• 8.TMMDA Turkish Drug and Medical Device Agency. Guideline on Good Pharmacovigilance Practices: Module I - Management and reporting of adverse drug reactions Guideline on Good Pharmacovigilance Practices: Appendıx I – Definitions, 2014.
• 9.Guner MD, Ekmekci PE. Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. J Drug Assess. 2019; 8(1):13-20
• 10.TMMDA. T.C. Sağlık Bakanlığı Türkiye Tıbbi Cihaz Sektörü Strateji Belgesi Ve Eylem Planı 2016-2020; 1-19
• 11.Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018; 25;9:9.
• 12.TMMDA. Notification on the principles and procedures related to the warning system of medical devices 2010, cited 12.03.2019 http://www.farmakovijilansdernegi.org/files/2010.07.14_Notification_on_the_principles_and_procedures_related_to_the_warning_system_of_medical_devices
• 13.Fitzpatrick D. Implantable Electronic Medical Devices, 1st ed. ISBN: 9780124165779; 2014.
• 14. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley T, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BM J 2004.;329(7456):15–9.
• 15.Angamo MT, Chalmers L, Curtain CM, Bereznicki LRE. Adverse drug reaction related hospitalisations in developed and developing countries: a review of prevalence and contributing factors. Drug Saf. 2016;39(9):847–57.
• 16.Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PM, HARM Study group. Frequency of and risk factors for preventable medication related hospital admissions in The Netherlands. Arch Intern Med. 2008;168(17):1890–6.
• 17.Vural F, Ciftci S, Vural B. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. Northern Clinics of İstanb. 2015;1(3):
• 18.Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci. 2008 ;30(5):556-62
• 19.Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int. health. 2018. DOI: 10.1093/inthealth/ihy073
• 20.Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol. 2013;45(6):616-8
• 21.Aydınkarahaliloğlu N.D., Aykaç E, Atalan Ö, Demir N, HayranM. Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016. Pharmaceutical Medicine 2018;32:353–364
• 22. Directive 2001/83/EC European Parliament. Draft European Parliament Legislative Resolution: proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0665 – C6 0514/2008- 2008/0260(COD)). Committee on the Environment, Public Health and Food Safety, European Parliament, Strasbourg, Session Document A7–0159/2010, 2010 www.europarl.europa.eu/sides/getDoc. do?pubRef=-//EP// NONSGML+REPORT+A7-2010-0159+0+DOC+WORD+V0//EN
• 23.Daughton CG, Ruhoy IS. Green pharmacy and pharmEcovigilance: prescribing and the planet. Expert Rev Clin Pharmacol. 2011; 2:211-32
• 24.Daughton CG, Ruhoy IS. The afterlife of drugs and the role of pharmEcovigilance. Drug Saf.2008; 31(12):1069-82.
• 25.Velo G, Moretti U. Ecopharmacovigilance for better health. Drug Saf. 2010; 33(11):963-8
• 26.Holm G, Snape JR, Murray-Smith R, Talbot J, Taylor D, Sörme P. Implementing ecopharmacovigilance in practice: challenges and potential opportunities. Drug Saf. 2013 ;36(7):533-46
• 27.Daughton CG. Eco-directed sustainable prescribing: feasibility for reducing water contamination by drugs. Sci Total Environ. 2014; 493:392-404.
• 28.Daughton CG, Ruhoy IS. Lower-dose prescribing: minimizing "side effects" of pharmaceuticals on society and the environment. Sci Total Environ. 2013 ;443:324-37.
• 29.YÖK Tıp eğitiminde intörnlük çalıştayı 10.01.2018, cited 12.03.2019, https://www.yok.gov.tr/Documents/Yayinlar/Yayinlarimiz/Tip_egitiminde_intornluk_calistayi.pdf
• 30.Gulpinar M, Vitrinel A. Evaluation of the undergraduate medical education national core curriculum-2014: National frame of medical education in Turkey. KMJ 2018; 50(1): 43-53
• 31.Turkish Interuniversity Council. National Core Curriculum 2014. Cited http://www.yok.gov.tr/documents/10279/27821052/tip_fakultesi_cekirdek_egitim_mufredati.pdf
• 32 Guner MD. Incentives to Increase Pharmacovigilance Practices from an Educational and Ethical Point of View. J of Pharmacol & Clin Res. 2017;3 (5)
• 33.Kummerer K, Velo G. Ecopharmacology: a new topic of importance in pharmacovigilance. Drug Saf. 2006;29(5):371–3.
• 34.Rahman SZ, Khan RA. Environmental pharmacology: a new discipline. Indian J Pharmacol. 2006;38:229–30.
• 35.Rahman SZ, Khan RA, Gupta V, Uddin M. Pharmacoenvironmentology: a component of pharmacovigilance. Environ Health2007.;6:20.
• 36.Taylor D. Chapter 7 - Ecopharmacostewardship – A Pharmaceutical Industry Perspective, In: K. Kümmerer, M. Hempel (eds.), Green and Sustainable Pharmacy, DOI 10.1007/978-3-642-05199-9_7, C Springer-Verlag Berlin Heidelberg, 2010
• 37. Murray-Smith R. Ecopharmacovigilance: a drug company per-spective. 10th Annual Meeting of the International Society of Pharmacovigilance, Accra, Ghana. 2010. Cited 04.04.13 http://isop2010.isoponline.org/uploads/prog/Programme_-3rd_-_7th_November-.pdf. Accessed 4 Apr 2013
• 38. Van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L. What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects. Drug Saf. 2018;41(11):1003-1011
• 39.LAREB, Netherlands Pharmacovigilance Centre Lareb,cited 03.01.17 https://www.pv-education.org/
• 40.GVP Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population, 2008, cited:19.03.2019 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-iv_en-0.pdf